keep Therapeutic Goods Regulations (Amendment)
Amendment to Therapeutic Goods Regulations governing the supply, manufacture, import, and export of therapeutic goods (medicines, medical devices, biologicals) in Australia. Establishes compliance requirements, registration/listing processes, advertising rules, and TGA administrative powers.
Therapeutic goods regulations serve a legitimate public health function by addressing genuine information asymmetries—consumers cannot independently verify drug safety or efficacy before consumption. Unlike many regulations that merely transfer wealth or create barriers without justification, therapeutic goods regulation mitigates real externalities where defective medicines or devices can cause harm beyond the immediate purchaser. While the TGA regime could benefit from Streamlining, mutual recognition agreements with trusted jurisdictions, and faster approval timelines, deletion entirely would create a regulatory vacuum susceptible to exploitation, endangering public health and undermining confidence in Australia's pharmaceutical and medical device sectors—significant contributors to exports and the healthcare system. The compliance burden, while real, must be weighed against the catastrophic potential harm from unregulated therapeutic goods.